The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Cement Restrictor System.
| Device ID | K060132 |
| 510k Number | K060132 |
| Device Name: | SPINAL USA CEMENT RESTRICTOR SYSTEM |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | SPINAL USA 213 EASTSIDE LANE Brandon, MS 39047 |
| Contact | Jeffrey Johnson |
| Correspondent | Jeffrey Johnson SPINAL USA 213 EASTSIDE LANE Brandon, MS 39047 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-18 |
| Decision Date | 2006-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840019929271 | K060132 | 000 |
| 00840019908849 | K060132 | 000 |
| 00840019908832 | K060132 | 000 |
| 00840019908825 | K060132 | 000 |
| 00840019908818 | K060132 | 000 |
| 00840019908801 | K060132 | 000 |
| 00840019908795 | K060132 | 000 |
| 00840019908788 | K060132 | 000 |
| 00840019908771 | K060132 | 000 |
| 00840019908764 | K060132 | 000 |
| 00840019908856 | K060132 | 000 |
| 00840019908863 | K060132 | 000 |
| 00840019929264 | K060132 | 000 |
| 00840019929240 | K060132 | 000 |
| 00840019929257 | K060132 | 000 |
| 00840019929233 | K060132 | 000 |
| 00815362022122 | K060132 | 000 |
| 00840019908900 | K060132 | 000 |
| 00840019908894 | K060132 | 000 |
| 00840019908887 | K060132 | 000 |
| 00840019908870 | K060132 | 000 |
| 00840019908757 | K060132 | 000 |